510(k) K900964
- Device
- CANNULA AND TROCAR, 11MM
- Applicant
- SOLOS ENDOSCOPY, INC.
- 510(k) number
- K900964
- Product code
- FBM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-04-18
- Date received
- 1990-02-27
- Regulation
- 876.5090
- Classification name
- Cannula And Trocar, Suprapubic, Non-disposable
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEILA H HOLMES
- Address
- 6191 Atlantic Blvd. Suite 4 Norcross GA US 30071 30071
FDA Registration Numbers#
- 3030839824
- 3008262872
- 3003759558
- 1651252
- 9611102
- 3008902714
- 9710524
- 3006554912
- 3008017452
- 3015398570
- 3013497507
- 1421879
- 3022862651
- 1320894
- 3029082594
- 1424478
- 2916714
- 3008853989
- 3007773213
- 3005528784
- 9611590
- 2431166
- 2183570
- 1417592
- 3035708926
- 3010687973
- 9613079
- 3004491689
- 3016248634
- 2424366
- 3008770252
- 3003882387
- 9680718
- 3010202439
- 2020550
- 3008843439
- 3010131137
- 3009513193
- 3015895045
- 8010099
- 3007648354
- 8010298
- 3011137372
- 3006082230
- 1319639
- 1018233
- 3005695838
- 8040233
- 3010041511
- 8040278
- 3008808049
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FBM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960400 | DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) | Snowden-Pencer | 1996-03-12 |
| K932021 | ENTREE CANNULA FASCIA ANCHORS | Core Dynamics, Inc. | 1994-01-11 |
| K911813 | ENTREE CANNULA | Core Dynamics, Inc. | 1991-07-19 |
| K900955 | GS-4000 REDUCER SLEEVE, 11MM TO 5MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900961 | GS-4100 REDUCER SLEEVE, 5MM TO 3MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900962 | GS-4300 CANNULA AND TROCAR, 5.5MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900963 | GS-4350 TROCAR ONLY, 5.5MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K900965 | GS-4550 TROCAR ONLY, 11MM | Solos Endoscopy, Inc. | 1990-04-18 |
Legacy Summary#
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FDA Review#
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