FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)
K Number: K882761
·
Decision Sep 20, 1988
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
170
Applicant Total
14
Review Days
76
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE)
- K Number
- K882761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Intramed Laboratories, Inc.
- Date Received
- July 6, 1988
- Decision Date
- September 20, 1988
- Product Code
- HIH
- 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 |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIH), ordered by most recent decision date.
Strauss Surgical Resection Instruments
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Manual Tissue Removal Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
InnovexView (GC146-17, GC150-20, GC155-23)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPY Cystoscope/Hysteroscope
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RZ Resectoscope System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Intramed Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953258 | TITANIUM HEMOSTATIC CLIP | Jan 5, 1996 | Substantially Equivalent |
| K942457 | GRAFT THROMBECTOMY INSTRUMENTS | Feb 7, 1995 | Substantially Equivalent |
| K931792 | ARTHROSCOPE | Jun 13, 1994 | Substantially Equivalent |
| K925283 | VALVULOTOME | Feb 10, 1994 | Substantially Equivalent |
| K934696 | ANGIOSCOPE | Jan 18, 1994 | Substantially Equivalent |
| K922114 | ENDOSCOPIC RETRIEVAL BASKET | Aug 3, 1992 | Substantially Equivalent |
| K914385 | OPTICAL VALVULOTOME | Mar 2, 1992 | Substantially Equivalent |
| K904465 | FLEXIBLE ARTHROSCOPE | Dec 20, 1990 | Substantially Equivalent |
| K903528 | LAPAROSCOPE | Sep 4, 1990 | Substantially Equivalent |
| K902444 | CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP | Aug 30, 1990 | Substantially Equivalent |