5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD
FDA 510(k) clearance K934510 · decided 1994-02-17
Clearance details
- K-number
- K934510
- Device name
- 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD
- Applicant
- Phx Technologies Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-14
- Decision date
- 1994-02-17
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- GCL
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lewisville, 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 |
|---|---|---|
| FE-24X, FIBER ESOPHAGOSCOPE (K951197) | Pentax Precision Instrument Corp. | 1995-05-30 |
| FE-34TH, FIBER ESOPHAGOSCOPE (K951198) | Pentax Precision Instrument Corp. | 1995-05-30 |
| BARD BIOPSY FORCEPS (K922086) | C.R. Bard, Inc. | 1992-10-30 |
Recalls involving this device
No recalls on record reference this clearance.