FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUTURE APPLIER DEVICE
K Number: K905722
·
Decision Mar 14, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
84
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
- SUTURE APPLIER DEVICE
- K Number
- K905722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Laparomed Corp.
- Date Received
- December 20, 1990
- Decision Date
- March 14, 1991
- Product Code
- MFJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| MFJ | Device, Endoscopic Suturing | FDA class 2 | Gastroenterology, Urology |
Other Clearances by Laparomed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K934527 | FASCIA STITCHER | Feb 25, 1994 | Substantially Equivalent |
| K930569 | LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM | Apr 20, 1993 | Substantially Equivalent |
| K921921 | CATHETER CHOLANGIOGRAPHY | Aug 17, 1992 | Substantially Equivalent |
| K921053 | LAPAROMED LIGATING LOOP | Aug 6, 1992 | Substantially Equivalent |
| K921006 | LAPAROSCOPIC RETRACTOR SYSTEM | Jul 28, 1992 | Substantially Equivalent |
| K914066 | ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS | Nov 7, 1991 | Substantially Equivalent |
| K910074 | LAPAROMED HOOK/SPATULA DEVICE | Jul 2, 1991 | Substantially Equivalent |
| K910219 | LAPAROMED CHOLANGIOGRAM DEVICE | Apr 8, 1991 | Substantially Equivalent |
| K910218 | LAPAROMED CHOLANGIOGRAM VACUUM DEVICE | Apr 8, 1991 | Substantially Equivalent |