FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYDROLOGY 5000
K Number: K955339
·
Decision Mar 13, 1996
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
76
Applicant Total
55
Review Days
114
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
- HYDROLOGY 5000
- K Number
- K955339
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Northgate Technologies, Inc.
- Date Received
- November 20, 1995
- Decision Date
- March 13, 1996
- Product Code
- GBX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBX | Catheter, Irrigation | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBX), ordered by most recent decision date.
MOERAE VEIN PREPARATION KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GRAFTGUARD PRESSURE CONTROLLING SYRINGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GRAFTSAVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MISONIX IRRIGATION SYSTEM MOEDL BC20P
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Northgate Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202813 | URO-TOUCH 9 French Probe | Jun 14, 2021 | Substantially Equivalent |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | Mar 25, 2021 | Substantially Equivalent |
| K130368 | AUTOLITH TOUCH; URO TOUCH | Nov 15, 2013 | Substantially Equivalent |
| K120151 | NEBULAE I | Aug 17, 2012 | Substantially Equivalent |
| K041560 | FLO-ASSISTANT | Sep 28, 2004 | Substantially Equivalent |
| K033614 | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 | Jul 29, 2004 | Substantially Equivalent |
| K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | Jan 24, 2003 | Substantially Equivalent |
| K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 | Oct 23, 2001 | Substantially Equivalent |
| K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 | Aug 10, 2001 | Substantially Equivalent |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | Aug 18, 2000 | Substantially Equivalent |