FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYSTEROMAT(TM) 3700
K Number: K921871
·
Decision Dec 15, 1994
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
55
Applicant Total
12
Review Days
969
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Basic Information
- Device Name
- HYSTEROMAT(TM) 3700
- K Number
- K921871
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1700
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- F.M. Wiest USA, Inc.
- Date Received
- April 20, 1992
- Decision Date
- December 15, 1994
- Product Code
- HIG
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIG | Insufflator, Hysteroscopic | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by F.M. Wiest USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920574 | CAMSYS 6300 | Feb 17, 1993 | Substantially Equivalent |
| K920575 | MERKUR 4000 | Jul 23, 1992 | Substantially Equivalent |
| K915751 | URETEROMAT 4400 | Apr 24, 1992 | Substantially Equivalent |
| K911844 | HYSTEROFLATOR 1500 | Nov 21, 1991 | Substantially Equivalent |
| K912071 | SPACE(TM) 7500 | Jul 9, 1991 | Substantially Equivalent |
| K910883 | LAPAROFLATOR ELECTRONIC 3509 | Mar 29, 1991 | Substantially Equivalent |
| K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC | Mar 2, 1988 | Substantially Equivalent |
| K871181 | ARTHROCOMBI 5003 | Sep 29, 1987 | Substantially Equivalent |
| K871180 | ARTHRO AUTOMAT 5002 | Sep 29, 1987 | Substantially Equivalent |
| K865066 | ARTHROFLATOR | Apr 20, 1987 | Substantially Equivalent |