MUCOUS SPECIMEN TRAP
FDA 510(k) clearance K913643 · decided 1991-10-10
Clearance details
- K-number
- K913643
- Device name
- MUCOUS SPECIMEN TRAP
- Applicant
- Medical Device Inspection Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-14
- Decision date
- 1991-10-10
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- BYZ
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Great Neck, NY, 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 |
|---|---|---|
| ELECTROMEDICS TISSUE TRAP/ #TT280 (K925412) | Electromedics, Inc. | 1993-02-05 |
| TISSUE/POLYP TRAP SYSTEM (K902883) | Triton Technology, Inc. | 1990-09-12 |
| BUSH NECK W/PLUG (K841409) | Warne Surgical Products, Ltd. | 1984-04-18 |
| ONE-WAY AIR VALVE (K840253) | Delta Medical Industries | 1984-04-05 |
| SPECIMEN TRAP (K834467) | Microvasive | 1984-02-17 |
| CRITICAL MEASUREMENT UNIT (K822556) | Bemis Health Care | 1982-10-18 |
| SPECIMEN ADAPTOR (K822557) | Bemis Health Care | 1982-10-18 |
| ASPRI-LUKE (K791847) | Medical Marketing Group | 1979-10-02 |
Recalls involving this device
No recalls on record reference this clearance.