GS-4000 REDUCER SLEEVE, 11MM TO 5MM
FDA 510(k) clearance K900955 · decided 1990-04-18
Clearance details
- K-number
- K900955
- Device name
- GS-4000 REDUCER SLEEVE, 11MM TO 5MM
- Applicant
- Solos Endoscopy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-27
- Decision date
- 1990-04-18
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- FBM
- Device class
- 1
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Norcross, GA, 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 |
|---|---|---|
| DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) (K960400) | Snowden-Pencer | 1996-03-12 |
| ENTREE CANNULA FASCIA ANCHORS (K932021) | Core Dynamics, Inc. | 1994-01-11 |
| ENTREE CANNULA (K911813) | Core Dynamics, Inc. | 1991-07-19 |
| GS-4550 TROCAR ONLY, 11MM (K900965) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-4300 CANNULA AND TROCAR, 5.5MM (K900962) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-4100 REDUCER SLEEVE, 5MM TO 3MM (K900961) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-4350 TROCAR ONLY, 5.5MM (K900963) | Solos Endoscopy, Inc. | 1990-04-18 |
| CANNULA AND TROCAR, 11MM (K900964) | Solos Endoscopy, Inc. | 1990-04-18 |
Recalls involving this device
No recalls on record reference this clearance.