510(k) K012198
- Device
- GIBBONS STERILE TROCAR KITS
- Applicant
- Gibbons Surgical Corp.
- 510(k) number
- K012198
- Product code
- FBQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-09
- Date received
- 2001-07-13
- Regulation
- 876.5090
- Classification name
- Trocar, Gastro-Urology
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- LISA CRISSON
- Address
- 1112 Jensen Dr., Suite 101 Virginia Beach VA US 23451 23451
FDA Registration Numbers
- 1018470
- 3030839824
- 9611102
- 1219930
- 3006546082
- 3004361445
- 9680515
- 3003418325
- 9610612
- 3015398570
- 8043769
- 2916714
- 9617744
- 3030447506
- 8043746
- 3030446844
- 8043548
- 3005987240
- 1825146
- 3016248634
- 3010011359
- 3010707607
- 3010303097
- 3003882387
- 9610617
- 9680718
- 3010202439
- 9612501
- 3018094310
- 2020550
- 2433012
- 1820334
- 3014342096
- 3015972835
- 3012494290
- 3013557562
- 2647580
- 3008808049
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FBQ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K980804 | SABRE BT BLUNT0TIP SURGICAL TROCAR | Endoscopic Concepts, Inc. | 1998-04-01 |
| K944640 | LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT | Gabris Surgical Corp. | 1994-10-11 |
| K944104 | GABRIS LAPAROSCOPIC SURGICAL KITS | Gabris Surgical Corp. | 1994-09-13 |
| K942885 | AUTO SUTURE MODIFIED GRIP | United States Surgical, A Division of Tyco Healthc | 1994-08-22 |
| K934724 | AESCULAP TROCAR INSTRUMENT SET | Aesculap, Inc. | 1993-12-23 |
| K904638 | TROCAR DISPOSABLE | L.A.S.E.R., Inc. | 1991-02-21 |
| K900123 | AUTO SUTURE SURGIPORT SPIRAL SLEEVE | United States Surgical, A Division of Tyco Healthc | 1990-04-04 |
| K841716 | ENDOPORT EROCAR | Endotherapeutics | 1984-06-28 |