ALLEN UNIVERSAL STIRRUP
FDA 510(k) clearance K860177 · decided 1986-02-11
Clearance details
- K-number
- K860177
- Device name
- ALLEN UNIVERSAL STIRRUP
- Applicant
- Edgewater Medical Equipment Systems
- Decision
- Substantially Equivalent
- Date received
- 1986-01-17
- Decision date
- 1986-02-11
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- BWN
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mayfield Hts., 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 |
|---|---|---|
| AIRFRAME SURGICAL DRAPE SUPPORT (K942699) | Alpha Surgical, Inc. | 1994-07-13 |
| INFINITECH BREATH EZ (K935441) | Infinitech, Inc. | 1994-02-07 |
| ISI SELF-SUPPORTING ARM (K925005) | Instrumentation Specialties, Inc. | 1993-04-29 |
| HOLDER, PEDIATRIC POSITION (K922288) | Yamashita and Hemsley Business Trust | 1993-02-10 |
| SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (K910783) | Smith & Nephew Equipment Group | 1991-04-02 |
| BAUMER SURGICAL TABLE (K902865) | Sds Dental, Inc. | 1990-09-10 |
| IOP ADJUSTABLE STIRRUP (K884558) | Mend Technologies, Inc. | 1988-11-17 |
| SPINAL SURGERY FRAME (K875291) | T. Korossurgical Instruments Corp. | 1988-01-22 |
| ENDOSCOPY TABLE 1532 ENDOSTAR (K873272) | Stierlen-Maquet AG | 1987-09-08 |
| TABLE ACCESSORIES, OPERATING ROOM (K852332) | Scholten Surgical Instruments, Inc. | 1985-07-02 |
| GUIDE TO THE KNEE (K843121) | Dyonics, Inc. | 1984-09-07 |
| OPERATING ROOM TABLES HYDRAULIC (K832340) | Kamiya Tsusan Kaisha, Ltd. | 1983-08-12 |
Recalls involving this device
No recalls on record reference this clearance.