IMC ENDOSCOPIC INSTRUMENT HOLDER
FDA 510(k) clearance K933371 · decided 1993-08-06
Clearance details
- K-number
- K933371
- Device name
- IMC ENDOSCOPIC INSTRUMENT HOLDER
- Applicant
- Inman Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-09
- Decision date
- 1993-08-06
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GCS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Fort Worth, TX, 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 |
|---|---|---|
| LAPRASCOPIC GRASPER (K944062) | Instrument Makar, Inc. | 1995-02-23 |
| PEANUT WAND, MODIFICATION (K944067) | Ideal Medical, Inc. | 1994-12-08 |
| AESCULAP TROCAR INSTRUMENT SET (K933201) | Aesculap, Inc. | 1993-09-13 |
| 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (K932762) | Inman Medical Corp. | 1993-08-31 |
| LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS (K924134) | Leisegang Medical, Inc. | 1993-07-02 |
| GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR (K931340) | Baxter Healthcare Corp | 1993-07-01 |
| M.I.S. TROCAR-CANNULA (K925276) | M.I.S. Technology, Inc. | 1993-05-24 |
| LAPAROSCOPIC RETRACTOR SYSTEM (K921006) | Laparomed Corp. | 1992-07-28 |
Recalls involving this device
No recalls on record reference this clearance.