Unisurge, Inc.
Mountain View, CA, US
Unisurge, Inc. appears in FDA device records in Mountain View, CA. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Unisurge, Inc. between 1992 and 1994. The busiest year on record is 1993, with 9. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 9 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K943502 | UNIGRIP | GCJ | Substantially Equivalent | |
| K933720 | INSTRUMENT ACTUATING DEVICE (IAD) | GCJ | Substantially Equivalent | |
| K930605 | APPLIER, SURGICAL, CLIP | GCJ | Substantially Equivalent | |
| K930617 | OBGRIP AND UNITIPS(TM) | GCJ | Substantially Equivalent | |
| K932604 | UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC | GCJ | Substantially Equivalent | |
| K930809 | UNITIPS | GCJ | Substantially Equivalent | |
| K925917 | UNICHANNEL(TM SURGICAL GRASPER | GCJ | Substantially Equivalent | |
| K925882 | UNITIPS SURGICAL INSTRUMENTS | GCJ | Substantially Equivalent | |
| K926341 | UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT | GCJ | Substantially Equivalent | |
| K926199 | UNICLIP SURGICAL CLIP APPLIER | GDO | Substantially Equivalent | |
| K914923 | UNISURGE DISPOSABLE TROCAR | HET | Substantially Equivalent | |
| K915372 | MANUAL SURGICAL INSTRMENTS FOR LAPAROSCOPY | GCJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain