MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE
FDA 510(k) clearance K860102 · decided 1986-02-12
Clearance details
- K-number
- K860102
- Device name
- MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE
- Applicant
- Endotherapeutics
- Decision
- Substantially Equivalent
- Date received
- 1986-01-10
- Decision date
- 1986-02-12
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- FHP
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Redwood City, CA, 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 |
|---|---|---|
| ENDOPATH VERESS NEEDLE (K910855) | Symbiosis Corp. | 1991-04-18 |
Recalls involving this device
No recalls on record reference this clearance.