FE-34TH, FIBER ESOPHAGOSCOPE
FDA 510(k) clearance K951198 · decided 1995-05-30
Clearance details
- K-number
- K951198
- Device name
- FE-34TH, FIBER ESOPHAGOSCOPE
- Applicant
- Pentax Precision Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-16
- Decision date
- 1995-05-30
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- GCL
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miramar, FL, 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 |
| 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD (K934510) | Phx Technologies Corp. | 1994-02-17 |
| BARD BIOPSY FORCEPS (K922086) | C.R. Bard, Inc. | 1992-10-30 |
Recalls involving this device
No recalls on record reference this clearance.