SHEATH, RESECTOSCOPE
FDA 510(k) clearance K760182 · decided 1976-12-02
Clearance details
- K-number
- K760182
- Device name
- SHEATH, RESECTOSCOPE
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-07-06
- Decision date
- 1976-12-02
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- FDC
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR (K021166) | Acmi-Circon Corporation | 2002-05-09 |
| OLYMPUS WORKING ELEMENT FOR PROBES (K992141) | Olympus Winter & Ibe GmbH | 1999-09-29 |
| MAHE INSTRUMENTS (K991426) | Mahe Intl., Inc. | 1999-08-05 |
| CONTINUOUS FLOW BIOPSY PROBE (K942626) | Gm Engineering, Inc. | 1995-05-30 |
| GM CONTINUOUS FLOW BIOPSY PROBE (K933962) | Gm Engineering, Inc. | 1994-02-25 |
| MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM (K895643) | Orthoconcept, Inc. | 1989-10-17 |
| UROPUMP* FLUID MANAGEMENT SYSTEM (K894363) | Orthoconcept, Inc. | 1989-08-11 |
| LASER RECTOSCOPE SET 784 (K842997) | Laser Industries , Ltd. | 1984-08-27 |
| ELEMENT, WORKING (K760184) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| ADAPTER, RESECTOSCOPE (K760174) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-30 |
Recalls involving this device
No recalls on record reference this clearance.