ENDOPATH VERESS NEEDLE
FDA 510(k) clearance K910855 · decided 1991-04-18
Clearance details
- K-number
- K910855
- Device name
- ENDOPATH VERESS NEEDLE
- Applicant
- Symbiosis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-28
- Decision date
- 1991-04-18
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- FHP
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miami Lakes, 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 |
|---|---|---|
| MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE (K860102) | Endotherapeutics | 1986-02-12 |
Recalls involving this device
No recalls on record reference this clearance.