FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
S1 ORAL PACKING
K Number: K861446
·
Decision May 6, 1986
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
9
Review Days
19
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Basic Information
- Device Name
- S1 ORAL PACKING
- K Number
- K861446
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Surgical Specialties, Inc.
- Date Received
- April 17, 1986
- Decision Date
- May 6, 1986
- 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 Surgical Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930826 | SUTURE NONABSORBABLE - SILK | Jan 7, 1994 | Substantially Equivalent |
| K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES | Jan 7, 1994 | Substantially Equivalent |
| K932038 | SUTURE NONABSORBABLE- SILK, POLYESTER | Jan 7, 1994 | Substantially Equivalent |
| K932037 | SUTURE ABSORBABLE- GUT | Jan 7, 1994 | Substantially Equivalent |
| K874219 | S3 MEDICATED GAUZE | Nov 23, 1987 | Substantially Equivalent |
| K861443 | S1 VAGINAL PACKING | May 6, 1986 | Substantially Equivalent |
| K861444 | S1 NASAL PACKING | May 6, 1986 | Substantially Equivalent |
| K861445 | S1 CAVITY PACKING | May 6, 1986 | Substantially Equivalent |