Endopouch Pro Specimen Retrieval Bag
FDA 510(k) K981579 · ETHICON, Inc.
510(k) numberK981579
Submission
- Device name
- Endopouch Pro Specimen Retrieval Bag
- Applicant
- ETHICON, Inc.
Somerville, NJ, US - Received
- May 4, 1998
- Decision date
- July 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Endopouch Pro Specimen Retrieval Bag cleared by the FDA?
Endopouch Pro Specimen Retrieval Bag (K981579) received a 510(k) decision of Substantially Equivalent on July 9, 1998, 66 days after the submission was received.
What is the product code of K981579?
The FDA product code is MDM – Instrument, Manual, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.