FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARLOW ANAL SPECULUM
K Number: K891352
·
Decision Jun 23, 1989
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
12
Review Days
105
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
- MARLOW ANAL SPECULUM
- K Number
- K891352
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Simpson/Basye, Inc.
- Date Received
- March 10, 1989
- Decision Date
- June 23, 1989
- Product Code
- KOA
- 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 |
|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOA), ordered by most recent decision date.
FiXcision
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
URETHRAL SUTURE GUIDE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LI VASECTOMY
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
VASOVASOSTOMY SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
VESITEC SUTURE PASSER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
DDV LIGATOR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Simpson/Basye, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926179 | SEDLACEK HANDLE | Mar 25, 1994 | Substantially Equivalent |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | May 11, 1989 | Substantially Equivalent |
| K891347 | REID ENDOCERVICAL SPREADER | Mar 29, 1989 | Substantially Equivalent |
| K891350 | NEWPORT CERVICAL MANIPULATOR | Mar 29, 1989 | Substantially Equivalent |
| K891349 | CAMPION CERVICAL HOOK | Mar 29, 1989 | Substantially Equivalent |
| K891348 | CAMPION LASER FORCEPS | Mar 22, 1989 | Substantially Equivalent |
| K870276 | HEATED INSTRUMENT BATH | May 7, 1987 | Substantially Equivalent |
| K862717 | HAND MIRROR (ENDOSCOPE) | Jul 30, 1986 | Substantially Equivalent |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Jul 17, 1986 | Substantially Equivalent |
| K790923 | MI-MARK ENDOCERVICAL SAMPLING SET | Jun 22, 1979 | Substantially Equivalent |