FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
K Number: K030170
·
Decision Jul 28, 2003
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
69
Applicant Total
13
Review Days
192
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Basic Information
- Device Name
- REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
- K Number
- K030170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Opus Medical, Inc.
- Date Received
- January 17, 2003
- Decision Date
- July 28, 2003
- Product Code
- OCW
- 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 |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Opus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER | Dec 14, 2004 | Substantially Equivalent |
| K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE | Nov 12, 2004 | Substantially Equivalent |
| K042031 | OPUS SPEEDSTITCH SUTURE DEVICE | Oct 19, 2004 | Substantially Equivalent |
| K041440 | OPUS MAGNUM ANCHOR WITH INSERTER | Jun 25, 2004 | Substantially Equivalent |
| K033317 | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 | Dec 30, 2003 | Substantially Equivalent |
| K031083 | OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 | Jun 12, 2003 | Substantially Equivalent |
| K030235 | F1 DIODE LASER SYSTEM | Apr 23, 2003 | Substantially Equivalent |
| K023843 | SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE | Feb 14, 2003 | Substantially Equivalent |
| K022229 | SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 | Sep 6, 2002 | Substantially Equivalent |
| K020172 | OPUS MAGNUM ANCHOR & INSTRUMENT SET | Jul 22, 2002 | Substantially Equivalent |