Surgical Specialties Corp
Reading, PA, US
Surgical Specialties Corp appears in FDA device records in Reading, PA. FDA records list 33 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 9 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 33 510(k) clearances for Surgical Specialties Corp between 1986 and 2016. The busiest year on record is 2005, with 5. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 4 |
| 1987 | 1 |
| 1994 | 4 |
| 2000 | 3 |
| 2002 | 2 |
| 2004 | 3 |
| 2005 | 5 |
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 2 |
| 2014 | 4 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160744 | LOOK PTFE Suture | NBY | Substantially Equivalent | |
| K141778 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | GAM | Substantially Equivalent | |
| K141625 | POLYSYN SURGICAL SUTURE | GAM | Substantially Equivalent | |
| K141558 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE | GAM | Substantially Equivalent | |
| K140227 | MONODERM SURGICAL SUTURE | GAM | Substantially Equivalent | |
| K080985 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) | NEW | Substantially Equivalent | |
| K080680 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE | NEW | Substantially Equivalent | |
| K071989 | QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL | NEW | Substantially Equivalent | |
| K072028 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM | GAM | Substantially Equivalent | |
| K063680 | SHARPOINT PDO (POLYDIOXANONE) SUTURES | NEW | Substantially Equivalent | |
| K053380 | CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE | NEW | Substantially Equivalent | |
| K052962 | OPTIMIZED BARB DESIGN | GAW | Substantially Equivalent | |
| K052437 | MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE | GAM | Substantially Equivalent | |
| K050548 | CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS | GAW | Substantially Equivalent | |
| K050292 | SHARPOINT LUKENS BONE WAX | MTJ | Substantially Equivalent | |
| K050247 | CONTOUR NECKLIFT THREADS | GAW | Substantially Equivalent | |
| K042856 | CONTOUR FOREHEAD/BROWLIFT THREAD | GAW | Substantially Equivalent | |
| K041593 | FEATHERLIFT EXTENDED LENGTH APTOS THREAD | GAW | Substantially Equivalent | |
| K040477 | MONODERM | GAM | Substantially Equivalent | |
| K020882 | SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG | LZU | Substantially Equivalent | |
| K014021 | SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED | GAM | Substantially Equivalent | |
| K003015 | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD | GAN | Substantially Equivalent | |
| K002849 | PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES | HNO | Substantially Equivalent | |
| K001765 | LOOK COLLAGEN SPACERS, MODEL 1514B | KXK | Substantially Equivalent | |
| K932038 | SUTURE NONABSORBABLE- SILK, POLYESTER | GAT | Substantially Equivalent | |
| K932037 | SUTURE ABSORBABLE- GUT | GAR | Substantially Equivalent | |
| K930826 | SUTURE NONABSORBABLE - SILK | GAP | Substantially Equivalent | |
| K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES | GAP | Substantially Equivalent | |
| K874219 | S3 MEDICATED GAUZE | FRO | Substantially Equivalent | |
| K861446 | S1 ORAL PACKING | EFQ | Substantially Equivalent | |
| K861445 | S1 CAVITY PACKING | EFQ | Substantially Equivalent | |
| K861444 | S1 NASAL PACKING | EFQ | Substantially Equivalent | |
| K861443 | S1 VAGINAL PACKING | EFQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FRODressing, Wound, Drug
- EFQGauze/Sponge, Internal
- HNOKeratome, Ac-Powered
- LZUPlug, Punctum
- KXKSource, Brachytherapy, Radionuclide
- GANSuture, Absorbable, Synthetic
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAPSuture, Nonabsorbable, Silk
- GARSuture, Nonabsorbable, Synthetic, Polyamide
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- NEWSuture, Surgical, Absorbable, Polydioxanone
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- MTJWax, Bone
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1534-2024 | POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N | Complaints have been received with allegations of Incorrect Needle Curvature. | Class II | Open, Classified | |
| Z-2138-2011 | SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures. | Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk suture. | Terminated | ||
| Z-0034-2009 | 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures. | mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture | Terminated | ||
| Z-0085-06 | Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units. | mislabeled as double armed straight needle actually single armed straight needle | Terminated | ||
| Z-0936-04 | Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed) | sterilization method incorrect | Terminated | ||
| Z-0026-04 | Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives. | text on product handle is incorrect | Terminated | ||
| Z-0705-03 | Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm. | size mislabeled on product handle | Terminated | ||
| Z-0544-03 | 25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End | The wrong product in the box. | Terminated | ||
| Z-0543-03 | 25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End | The wrong product in the box. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain