Surgin Surgical Instrumentation, Inc.
Scottsdale, AZ, US
SURGIN SURGICAL INSTRUMENTATION, INC. appears in FDA device records in Scottsdale, AZ. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Surgin Surgical Instrumentation, Inc. between 1993 and 2009. The busiest year on record is 1994, with 14. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 14 |
| 1995 | 2 |
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2004 | 2 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082110 | DUAL SYRINGE HOLDER | FMG | Substantially Equivalent | |
| K033236 | PRIZM KERATOME BLADE, MODEL MK8512M2 | HNO | Substantially Equivalent | |
| K033182 | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD | HNO | Substantially Equivalent | |
| K011195 | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB | HNO | Substantially Equivalent | |
| K994015 | ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 | HNO | Substantially Equivalent | |
| K980849 | SURGIN KIT | MSR | Substantially Equivalent | |
| K954238 | SURGIN GENISIS HANDPIECE | HQC | Substantially Equivalent | |
| K950600 | VACUUM SURGE SUPRESSER | HQC | Substantially Equivalent | |
| K942945 | CASSETTE SYSTEM FOR STORZ | HQC | Substantially Equivalent | |
| K942944 | IRRIGATION/BIPOLAR SET | GEI | Substantially Equivalent | |
| K942897 | OPTHALMIC WIPE | HQZ | Substantially Equivalent | |
| K942807 | SURGICAL LIFT SHEET | FSA | Substantially Equivalent | |
| K943102 | HIGH PERFORMANCE TIPS | HQC | Substantially Equivalent | |
| K942518 | CASSETTE SYSTEM FOR SITE | HQC | Substantially Equivalent | |
| K942517 | 10-K CASSETTE | HQC | Substantially Equivalent | |
| K942516 | 10-0 CASSETTE | HQC | Substantially Equivalent | |
| K942515 | PHACO KIT | HQC | Substantially Equivalent | |
| K943070 | REUSABLE PROBES | GCJ | Substantially Equivalent | |
| K942896 | CLAMPS AND CLIPS | MDM | Substantially Equivalent | |
| K942642 | SURGI-WIPE | HOZ | Substantially Equivalent | |
| K942641 | SURGIN IRRIGATION PUMP | GCJ | Substantially Equivalent | |
| K935293 | FLUID ASPIRATION NEEDLE | GCJ | Substantially Equivalent | |
| K934173 | SUTURE HANDLER | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2023739 | 2023739 | SURGIN SURGICAL INSTRUMENTATION, INC. | 10040 E. Happy Valley Rd., Scottsdale, AZ 85255 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HQZFrame, Spectacle
- FZYHammer, Surgical
- KOHInstrument, Manual, General Obstetric-Gynecologic
- MDMInstrument, Manual, Surgical, General Use
- HNOKeratome, Ac-Powered
- GCJLaparoscope, General & Plastic Surgery
- FSALift, Patient, Non-Ac-Powered
- HOZSponge, Ophthalmic
- GDWStaple, Implantable
- FMGStopcock, I.V. Set
- KYZSyringe, Irrigating (Non Dental)
- MSRTubing, Replacement, Phacofragmentation Unit
- HQCUnit, Phacofragmentation
Recall records
No recall records for this company in the ingested FDA data.
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 Surgin Surgical Instrumentation, Inc. 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