FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHARPS COLLECTION CONTAINER - SAF-T-SHELL
K Number: K982029
·
Decision Apr 6, 1999
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
301
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
- SHARPS COLLECTION CONTAINER - SAF-T-SHELL
- K Number
- K982029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Medical Mfg., Inc.
- Date Received
- June 9, 1998
- Decision Date
- April 6, 1999
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMI), ordered by most recent decision date.
Profoject Safety Pen Needles
FDA 510(k)
FDA Class 2
·General Hospital
Verisafe Safety Sterile Needles (SSN)
FDA 510(k)
FDA Class 2
·General Hospital
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
PRESSONE
FDA 510(k)
FDA Class 2
·General Hospital
Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by American Medical Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961454 | AMMI MAGNI-GUARD | Jul 25, 1996 | Substantially Equivalent |
| K915066 | DISPOSABLE SKIN MARKER | May 14, 1992 | Substantially Equivalent |
| K915064 | DISPOSABLE CAUTERY ABRASIVE PAD | Mar 11, 1992 | Substantially Equivalent |
| K915065 | I.V.IRRIGATION POLE | Feb 11, 1992 | Substantially Equivalent |
| K915068 | PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER | Feb 6, 1992 | Substantially Equivalent |