FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRICE SOFT TISSUE BIOPSY KIT
K Number: K922161
·
Decision Oct 13, 1992
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
16
Review Days
159
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Basic Information
- Device Name
- GRICE SOFT TISSUE BIOPSY KIT
- K Number
- K922161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ideal Medical, Inc.
- Date Received
- May 7, 1992
- Decision Date
- October 13, 1992
- Product Code
- KNW
- 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Ideal Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944067 | PEANUT WAND, MODIFICATION | Dec 8, 1994 | Substantially Equivalent |
| K931115 | HATCHER STONE-EMBOLIS EXTRACTOR | Aug 20, 1993 | Substantially Equivalent |
| K926335 | IDEAS PEANUT WAND | Jun 24, 1993 | Substantially Equivalent |
| K921922 | GRICE LAPAROSCOPIC SUTURING NEEDLE | Jul 8, 1992 | Substantially Equivalent |
| K915175 | REDDICK RETRACTOR | Apr 29, 1992 | Substantially Equivalent |
| K914880 | DUAL BALLOON EMBOLECTOMY CATHETER | Mar 16, 1992 | Substantially Equivalent |
| K913602 | IDEAS' PORT | Jan 2, 1992 | Unknown |
| K914913 | GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST | Dec 31, 1991 | Substantially Equivalent |
| K912540 | CONTOUR-PORT | Aug 23, 1991 | Unknown |
| K911601 | REDDICK TROCAR AND CANNULA | May 21, 1991 | Substantially Equivalent |