FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JAMES SURGICAL SYSTEM J1000
K Number: K890195
·
Decision Aug 3, 1989
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
14
Review Days
197
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Basic Information
- Device Name
- JAMES SURGICAL SYSTEM J1000
- K Number
- K890195
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- O.R. Specialties, Inc.
- Date Received
- January 18, 1989
- Decision Date
- August 3, 1989
- Product Code
- HQE
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by O.R. Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942607 | LAPAROSCOPIC SCISSORS (DISPOSABLE) | Jul 6, 1994 | Substantially Equivalent |
| K923630 | PHACO NEEDLES 1000-R & 1000-O NEEDLES | Apr 6, 1994 | Substantially Equivalent |
| K925671 | DISPOSABLE SCLERAL PLUGS | Aug 2, 1993 | Substantially Equivalent |
| K923887 | JACK'S VENT TUBES | Feb 19, 1993 | Substantially Equivalent |
| K923774 | DISPOSABLE ENDOILLUMINATOR | Oct 19, 1992 | Substantially Equivalent |
| K922355 | POLLY'S VITREOUS SCISSORS J-225-S | Aug 18, 1992 | Substantially Equivalent |
| K922180 | LEWICKY O.R.S. TUBING | Jul 2, 1992 | Substantially Equivalent |
| K914038 | POLLY'S CUTTER J-225 | Dec 9, 1991 | Substantially Equivalent |
| K911932 | J105 JAMES SURGICAL SYSTEM I/A PACK | Aug 26, 1991 | Substantially Equivalent |
| K891161 | VITRECTOMY PACK #J120 | May 26, 1989 | Substantially Equivalent |