Endopath Endoscopic Tissue Fastening System with Coated Vicryl, Models SW210, SW220, SW220,SW230, SW212, SW222 and SW232
FDA 510(k) K992612 · Ethicon Endo-Surgery, Inc.
510(k) numberK992612
Submission
- Device name
- Endopath Endoscopic Tissue Fastening System with Coated Vicryl, Models SW210, SW220, SW220,SW230, SW212, SW222 and SW232
- Applicant
- Ethicon Endo-Surgery, Inc.
Cincinnati, OH, US - Received
- August 4, 1999
- Decision date
- October 14, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Endopath Endoscopic Tissue Fastening System with Coated Vicryl, Models SW210, SW220, SW220,SW230, SW212, SW222 and SW232 cleared by the FDA?
Endopath Endoscopic Tissue Fastening System with Coated Vicryl, Models SW210, SW220, SW220,SW230, SW212, SW222 and SW232 (K992612) received a 510(k) decision of Substantially Equivalent on October 14, 1999, 71 days after the submission was received.
What is the product code of K992612?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.