O.R. Specialties, Inc.
Mchenry, IL, US
O.R. Specialties, Inc. appears in FDA device records in Mchenry, IL. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for O.R. Specialties, Inc. between 1981 and 1994. The busiest year on record is 1989, with 3. The most recent is 1994, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1988 | 1 |
| 1989 | 3 |
| 1991 | 2 |
| 1992 | 3 |
| 1993 | 2 |
| 1994 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K942607 | LAPAROSCOPIC SCISSORS (DISPOSABLE) | GEI | Substantially Equivalent | |
| K923630 | PHACO NEEDLES 1000-R & 1000-O NEEDLES | HQC | Substantially Equivalent | |
| K925671 | DISPOSABLE SCLERAL PLUGS | LXP | Substantially Equivalent | |
| K923887 | JACK'S VENT TUBES | ETD | Substantially Equivalent | |
| K923774 | DISPOSABLE ENDOILLUMINATOR | EQH | Substantially Equivalent | |
| K922355 | POLLY'S VITREOUS SCISSORS J-225-S | HQE | Substantially Equivalent | |
| K922180 | LEWICKY O.R.S. TUBING | KYG | Substantially Equivalent | |
| K914038 | POLLY'S CUTTER J-225 | HQE | Substantially Equivalent | |
| K911932 | J105 JAMES SURGICAL SYSTEM I/A PACK | GZX | Substantially Equivalent | |
| K890195 | JAMES SURGICAL SYSTEM J1000 | HQE | Substantially Equivalent | |
| K891161 | VITRECTOMY PACK #J120 | HQC | Substantially Equivalent | |
| K890825 | JUMPER PACK #203 | HQC | Substantially Equivalent | |
| K880062 | C-MATE #CMU 1001 | HQC | Substantially Equivalent | |
| K811951 | DRESSING CHANGE TRAYS & STERILE SPONGES | EFQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KYGDevice, Irrigation, Ocular Surgery
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- EFQGauze/Sponge, Internal
- GZXInstrument, Microsurgical
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- LXPPlug, Scleral
- EQHSource, Carrier, Fiberoptic Light
- ETDTube, Tympanostomy
- 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.
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Data as of , FDA export datePage updated Source: openFDA, public domain