FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM
K Number: K982073
·
Decision Sep 22, 1998
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
7
Review Days
102
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Basic Information
- Device Name
- ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM
- K Number
- K982073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Anchor Products Co.
- Date Received
- June 12, 1998
- Decision Date
- September 22, 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 Anchor Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K091930 | ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB | Sep 23, 2009 | Substantially Equivalent |
| K061555 | ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM | Aug 31, 2006 | Substantially Equivalent |
| K884862 | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE | Dec 27, 1988 | Substantially Equivalent |
| K873124 | ANCHOR BIOPSY NEEDLE | Sep 8, 1987 | Substantially Equivalent |
| K831648 | ANCHOR BRAND SURGICAL NEEDLES | Aug 16, 1983 | Substantially Equivalent |
| K790405 | ANCHOR BRAND COUNT-TAINER | Mar 26, 1979 | Substantially Equivalent |