Srm-Stitch 8F Srm-Stitch 8F with Guidewire
FDA 510(k) K113763 · Nobles Medical Technologies Ii, Inc.
510(k) numberK113763
Submission
- Device name
- Srm-Stitch 8F Srm-Stitch 8F with Guidewire
- Applicant
- Nobles Medical Technologies Ii, Inc.
Fountain Valley, CA, US - Received
- December 21, 2011
- Decision date
- March 16, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5010
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K173747 | RexleneGAW · Traditional | Sm Eng Co., Ltd. | 12/21/2018SE |
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Questions and answers
When was Srm-Stitch 8F Srm-Stitch 8F with Guidewire cleared by the FDA?
Srm-Stitch 8F Srm-Stitch 8F with Guidewire (K113763) received a 510(k) decision of Substantially Equivalent on March 16, 2012, 86 days after the submission was received.
What is the product code of K113763?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.