FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN
K Number: K830268
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
22
Review Days
134
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
- FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN
- K Number
- K830268
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Ritmed, Inc.
- Date Received
- January 25, 1983
- Decision Date
- June 8, 1983
- Product Code
- EFQ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
FDA 510(k)
FDA Unclassified
·Unknown
VITOP DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
FDA 510(k)
FDA Unclassified
·Unknown
CROSSTEX NON-WOVEN SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE, SPONGES, CAT # 11-003
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Ritmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K833626 | FLORET FOAM PREP SPONGE | Feb 17, 1984 | Substantially Equivalent |
| K832874 | ISOVIS WOUND PROTECTOR | Sep 26, 1983 | Substantially Equivalent |
| K830270 | ISOVIS WOUND PROTECTOR | Jun 24, 1983 | Substantially Equivalent |
| K830267 | FLORET SPECIAL GAUZE SPONGES | Jun 8, 1983 | Substantially Equivalent |
| K830261 | FLORET STRUNG GAUZE SPONGES | Jun 8, 1983 | Substantially Equivalent |
| K830266 | FLORET KITTNER OR K DISSECTOR | Jun 8, 1983 | Substantially Equivalent |
| K830272 | PROTET HOLDERS-BLOCKS & ROLL | Jun 3, 1983 | Substantially Equivalent |
| K830264 | FLORET TONSIL & ADENOID SPONGES | Jun 3, 1983 | Substantially Equivalent |
| K830271 | LAPET & LAPWALL LAPAROTOMY SPONGES | Jun 2, 1983 | Substantially Equivalent |
| K830269 | FLORET NEURO SPONGE | Jun 2, 1983 | Substantially Equivalent |