ENDOPORT EROCAR
FDA 510(k) clearance K841716 · decided 1984-06-28
Clearance details
- K-number
- K841716
- Device name
- ENDOPORT EROCAR
- Applicant
- Endotherapeutics
- Decision
- Substantially Equivalent
- Date received
- 1984-04-25
- Decision date
- 1984-06-28
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- FBQ
- Device class
- 2
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, 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 |
|---|---|---|
| GIBBONS STERILE TROCAR KITS (K012198) | Gibbons Surgical Corp. | 2001-08-09 |
| SABRE BT BLUNT0TIP SURGICAL TROCAR (K980804) | Endoscopic Concepts, Inc. | 1998-04-01 |
| LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT (K944640) | Gabris Surgical Corp. | 1994-10-11 |
| GABRIS LAPAROSCOPIC SURGICAL KITS (K944104) | Gabris Surgical Corp. | 1994-09-13 |
| AUTO SUTURE MODIFIED GRIP (K942885) | United States Surgical, A Division of Tyco Healthc | 1994-08-22 |
| AESCULAP TROCAR INSTRUMENT SET (K934724) | Aesculap, Inc. | 1993-12-23 |
| TROCAR DISPOSABLE (K904638) | L.A.S.E.R., Inc. | 1991-02-21 |
| AUTO SUTURE SURGIPORT SPIRAL SLEEVE (K900123) | United States Surgical, A Division of Tyco Healthc | 1990-04-04 |
Recalls involving this device
No recalls on record reference this clearance.