FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISION OPTICS CORPORATION LAPAROSCOPE
K Number: K911744
·
Decision Jul 26, 1991
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
13
Review Days
99
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Basic Information
- Device Name
- PRECISION OPTICS CORPORATION LAPAROSCOPE
- K Number
- K911744
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precise Optics
- Date Received
- April 18, 1991
- Decision Date
- July 26, 1991
- 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 Precise Optics
| K Number | Device Name | ||
|---|---|---|---|
| K030061 | PS 3000 DIGATAL PHOTOSPOT SYSTEM | Apr 7, 2003 | Substantially Equivalent |
| K935580 | PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER | Mar 16, 1994 | Substantially Equivalent |
| K932878 | PRECISION INTRA-ORAL SCOPES | Jan 6, 1994 | Substantially Equivalent |
| K914084 | ENDOSCOPES | Jan 22, 1992 | Substantially Equivalent |
| K914184 | P2020-8-0 BEAM-LIMITING DEVICE | Nov 27, 1991 | Substantially Equivalent |
| K903459 | PRECISION OPTICS ENDOSCOPE ADAPTER | Oct 26, 1990 | Substantially Equivalent |
| K903457 | PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) | Oct 19, 1990 | Substantially Equivalent |
| K903458 | PRECISION OPTICS IMAGE COUPLER | Oct 19, 1990 | Substantially Equivalent |
| K820178 | PI808 MOBILE C-ARM IMAGE INTENSIFIER | Mar 4, 1982 | Substantially Equivalent |
| K827087 | P1808 MOBILE C-ARM IMAGE INTENSIFIER | Mar 4, 1982 | Substantially Equivalent |