Symmetry Surgical GmbH
TUTTLINGEN Baden-Wurttemberg, DE
Symmetry Surgical GmbH appears in FDA device records in TUTTLINGEN Baden-Wurttemberg, DE. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Symmetry Surgical GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Symmetry Medical/SSIenforcement report, recall
510(k) clearance history
FDA records hold 5 510(k) clearances for Symmetry Surgical GmbH between 2013 and 2018. The busiest year on record is 2016, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173272 | Ergonomic Handle | GCJ | Substantially Equivalent | |
| K161744 | Symmetry Sharp Kerrison Rongeur | HAE | Substantially Equivalent | |
| K152111 | Symmetry Surgical Quad-Lock Container System | KCT | Substantially Equivalent | |
| K143078 | Bookwalter Gordon Adjustable Compression Element | DXC | Substantially Equivalent | |
| K130541 | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | HAE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001644167 | 3001644167 | Symmetry Surgical GmbH | MAYBACHSTRASSE 10, TUTTLINGEN Baden-Wurttemberg 78532 DE | 2026 | and 88 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- EMXBalloon, Epistaxis
- FAXBougie, Urological
- EKWBroach, Endodontic
- EPEBrush, Cleaning, Tracheal Tube
- EQJBur, Ear, Nose And Throat
- EKJBurnisher, Operative
- EMLChisel, Bone, Surgical
- EMMChisel, Osteotome, Surgical
- DXCClamp, Vascular
- EKTCurette, Endodontic
- EMSCurette, Periodontic
- EMKCurette, Surgical, Dental
- FFRDevice, Locking, For Intestinal Clamp
- FFPDilator, Rectal
- EMJElevator, Surgical, Dental
- FFDEvacuator, Bladder, Manually Operated
- EMIFile, Bone, Surgical
- EMRFile, Periodontic
- EKSFile, Pulp Canal, Endodontic
- FCLForceps, Biopsy, Non-Electric
- EMHForceps, Rongeur, Surgical
- EMGForceps, Tooth Extractor, Surgical
- EKMGutta-Percha
- EMDHemostat, Surgical
- EMQHoe, Periodontic
- EYJHolder, Ureteral Catheter
- FEXInstrument, Catheter, Punch
- ELAInstrument, Hand, Calculus Removal
- EMOKnife, Periodontic
- EMFKnife, Surgical
- EMPMarker, Periodontic
- EPTMicroscope, Surgical
- ERAOtoscope
- EKRPlugger, Root Canal, Endodontic
- EKLPoint, Silver, Endodontic
- ELRPost, Root Canal
- EKQPreparer, Root Canal Endodontic
- FGMProbe And Director, Gastro-Urology
- EXXProbe, Rectal, Non-Powered
- EMEPunch, Biopsy, Surgical
- EKPReamer, Pulp Canal, Endodontic
- FDGRetractor, Fiberoptic
- FGNRetractor, Non-Self-Retaining
- FFORetractor, Self-Retaining
- EMNScaler, Periodontic
- FBSSound, Metal, Interconnected
- FBXSound, Urethral, Metal Or Plastic
- EQHSource, Carrier, Fiberoptic Light
- EPYSpeculum, Ent
- FFQSpeculum, Rectal
- EPPSplint, Nasal
- EKKSpreader, Pulp Canal Filling Material, Endodontic
- EZBStylet For Catheter, Gastro-Urology
- EYAStylet, Ureteral
- EYRTourniquet, Gastro-Urology
- FCZTube, Smoke Removal, Endoscopic
- ETFUnit, Examining/Treatment, Ent
- EMBZinc Oxide Eugenol
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1012-2017 | symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-G, C22855-G, C22856-G, C22858-G, C24134-G, C24135-G, C24136-G, C24138, C24138-G Product Usage: sterilization container | Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization. | Class II | Terminated | |
| Z-1011-2017 | symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP, C24136-SP, C24138-SP Product Usage: sterilization container | Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization. | Class II | Terminated | |
| Z-1010-2017 | symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136 Product Usage: sterilization container | Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization. | Class II | Terminated | |
| Z-2316-2015 | SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape. | Lack of sterility assurance. | Class II | Terminated | |
| Z-0833-2014 | Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8748, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Small 4 Latch, REF 50-8950, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Small 4 Latch, REF 50-8951, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Green Small 4 Latch, REF 50-8952, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Blue Small 4 Latch, REF 50-8953, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Red Small 4 Latch, REF 50-8954, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Black Small 4 Latch, REF 50-8955, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Medium Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8736, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8737, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8738, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8749, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8750, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8751, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Medium 4 Latch, REF 50-8956, 445mm x 279mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Medium 4 Latch, REF 50-8957, 445mm x 279mm, QTY: 1, | The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier. | Class II | Terminated | |
| Z-1267-2013 | Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor | There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Symmetry Surgical GmbH edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain