FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKIN STAPLE EXTRACTOR
K Number: K811887
·
Decision Jul 27, 1981
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
3
Applicant Total
12
Review Days
26
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
- SKIN STAPLE EXTRACTOR
- K Number
- K811887
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Sierra Laboratories, Inc.
- Date Received
- July 1, 1981
- Decision Date
- July 27, 1981
- Product Code
- KBC
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KBC | Saw, Nasal | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KBC), ordered by most recent decision date.
AUTO SUTURE PSS SKIN STAPLING INSTRUMENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
AUTO SUTURE GAS POWERED DISP. LDS STAPL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
JOSEPH SAW
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Sierra Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | Apr 22, 1997 | Substantially Equivalent |
| K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER | Jul 15, 1996 | Substantially Equivalent |
| K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER | Jul 15, 1996 | Substantially Equivalent |
| K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER | Apr 19, 1994 | Substantially Equivalent |
| K934052 | ALPINE REUSABLE LEG BAGS | Jan 7, 1994 | Substantially Equivalent |
| K931156 | CONE CATH | Jul 1, 1993 | Substantially Equivalent |
| K901000 | URO TEX URINALS | Mar 26, 1990 | Substantially Equivalent |
| K883057 | COMFORT CATH MALE EXTERNAL CATHETER | Aug 2, 1988 | Substantially Equivalent |
| K873039 | MODEL 820 TOP=TRAK | Feb 11, 1988 | Substantially Equivalent |
| K832450 | URO-TEX MALE EXTERNAL CATHETER | Oct 14, 1983 | Substantially Equivalent |