HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
FDA 510(k) clearance K992390 · decided 1999-12-22
Clearance details
- K-number
- K992390
- Device name
- HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
- Applicant
- Telemed Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-19
- Decision date
- 1999-12-22
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- KGE
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.