FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
K Number: K874045
·
Decision Dec 3, 1987
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
2
Applicant Total
64
Review Days
59
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
- PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
- K Number
- K874045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Pharmaseal Div. Ahsc
- Date Received
- October 5, 1987
- Decision Date
- December 3, 1987
- Product Code
- NWU
- 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 |
|---|---|---|---|
| NWU | Endoscope Introducer Kit | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NWU), ordered by most recent decision date.
CANDELA GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BRISTOL BALLON INTRODUCER, MANDRIL SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by American Pharmaseal Div. Ahsc
| K Number | Device Name | ||
|---|---|---|---|
| K874022 | PHARMASEAL WOUND IRRIGATION DEVICE | Dec 30, 1987 | Substantially Equivalent |
| K874517 | PHARMASEAL RUBBER URETHRAL CATHETER | Dec 3, 1987 | Substantially Equivalent |
| K873359 | AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE | Nov 6, 1987 | Substantially Equivalent |
| K872228 | PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM | Sep 4, 1987 | Substantially Equivalent |
| K872917 | JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER | Aug 11, 1987 | Substantially Equivalent |
| K871429 | ANTIMICROBIAL FOLEY CATHETER | Aug 10, 1987 | Substantially Equivalent |
| K871770 | AMERICAN PHARMASEAL WOUND DRESSING | Jun 26, 1987 | Substantially Equivalent for Some Indications |
| K870387 | EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE | May 8, 1987 | Substantially Equivalent |
| K870977 | PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE | Apr 1, 1987 | Substantially Equivalent |
| K870941 | PHARMASEAL WOUND CARE DRESSING PAD | Mar 27, 1987 | Substantially Equivalent |