OBSTI-HOOK
FDA 510(k) clearance K951148 · decided 1995-06-09
Clearance details
- K-number
- K951148
- Device name
- OBSTI-HOOK
- Applicant
- Onli
- Decision
- Substantially Equivalent
- Date received
- 1995-03-13
- Decision date
- 1995-06-09
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HGE
- Device class
- 1
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Gahanna, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMNIPERF(TM) (K926425) | Raymart Development Co. | 1994-03-07 |
| GLOVE-N-GEL AMNIOTOMY KIT (K910518) | Epcom Medical Systems, Inc. | 1991-05-09 |
| S.C.M.T. PERFORATOR (K871087) | Salt Creek Medical Technologies | 1987-03-23 |
| AMNIGLOVE & AMNICOT (K850758) | Go Medical Industries Pty. , Ltd. | 1985-04-15 |
| H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 (K834177) | Imm Enterprises , Ltd. | 1983-12-27 |
Recalls involving this device
No recalls on record reference this clearance.