FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GS-4550 TROCAR ONLY, 11MM
K Number: K900965
·
Decision Apr 18, 1990
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
8
Applicant Total
21
Review Days
50
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Basic Information
- Device Name
- GS-4550 TROCAR ONLY, 11MM
- K Number
- K900965
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Solos Endoscopy, Inc.
- Date Received
- February 27, 1990
- Decision Date
- April 18, 1990
- Product Code
- FBM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FBM), ordered by most recent decision date.
DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
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ENTREE CANNULA
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CANNULA AND TROCAR, 11MM
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GS-4100 REDUCER SLEEVE, 5MM TO 3MM
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GS-4300 CANNULA AND TROCAR, 5.5MM
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Other Clearances by Solos Endoscopy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983538 | MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY | Nov 6, 1998 | Substantially Equivalent |
| K910671 | MODEL GS-4700 COMMON DUCT STONE REMOVING KIT | May 10, 1991 | Substantially Equivalent |
| K900964 | CANNULA AND TROCAR, 11MM | Apr 18, 1990 | Substantially Equivalent |
| K900959 | GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED | Apr 18, 1990 | Substantially Equivalent |
| K900957 | GS-2100 HOOK SUTURE SCISSOR, 5MM | Apr 18, 1990 | Substantially Equivalent |
| K900954 | GS-5200 HOOK SUCTION/COAGULATOR, 5MM | Apr 18, 1990 | Substantially Equivalent |
| K900961 | GS-4100 REDUCER SLEEVE, 5MM TO 3MM | Apr 18, 1990 | Substantially Equivalent |
| K900948 | GS-1002 GRASPING FORCEP, 5MM WITH RATCHET | Apr 18, 1990 | Substantially Equivalent |
| K900953 | GS-5000 SPATULA SUCTION/COAGULATOR, 5MM | Apr 18, 1990 | Substantially Equivalent |
| K900952 | GS-1200 GRASPING/EXTRACTING FORCEP, 10MM | Apr 18, 1990 | Substantially Equivalent |