FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPERAND LUBRICATING JELLY
K Number: K912132
·
Decision Aug 7, 1991
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
5
Applicant Total
15
Review Days
85
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
- OPERAND LUBRICATING JELLY
- K Number
- K912132
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Medical Co.
- Date Received
- May 14, 1991
- Decision Date
- August 7, 1991
- Product Code
- FHX
- 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 |
|---|---|---|---|
| FHX | Jelly, Lubricating, For Transurethral Surgical Instrument | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FHX), ordered by most recent decision date.
LUBRICANO STERILE GEL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BUTTON LUBRICATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CATHEJELL S STERILE LUBRICATING JELLY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
K-Y LUBRICATING JELLY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUBE JEL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by General Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K926269 | PROCEDURE KIT | Aug 27, 1993 | Unknown |
| K912975 | OPERAND LUBRICATING JELLY | Sep 27, 1991 | Substantially Equivalent |
| K903669 | GENESIS INSUFFLATING CATHETER | Sep 12, 1990 | Substantially Equivalent |
| K900110 | OPERAND* LUBRICATING JELLY | May 2, 1990 | Substantially Equivalent |
| K853635 | SUBDERM TM | Dec 20, 1985 | Substantially Equivalent |
| K844652 | C.A.S.E. CONTAINER | Dec 12, 1984 | Substantially Equivalent |
| K831320 | DRIONIC | Jul 19, 1983 | Substantially Equivalent |
| K820689 | C.S.R. WRAPPERS | Apr 9, 1982 | Substantially Equivalent |
| K820521 | STERILIZATION WRAP | Mar 18, 1982 | Substantially Equivalent |
| K802231 | AIR VIVA II | Oct 10, 1980 | Substantially Equivalent |