FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY
K Number: K983538
·
Decision Nov 6, 1998
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
21
Review Days
28
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Basic Information
- Device Name
- MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY
- K Number
- K983538
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solos Endoscopy, Inc.
- Date Received
- October 9, 1998
- Decision Date
- November 6, 1998
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Solos Endoscopy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K900965 | GS-4550 TROCAR ONLY, 11MM | 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 |