Stiegmann-Goff Endoscopic Ligator
FDA 510(k) K940661 · C.R. Bard, Inc.
510(k) numberK940661
Submission
- Device name
- Stiegmann-Goff Endoscopic Ligator
- Applicant
- C.R. Bard, Inc.
Tewksbury, MA, US - Received
- February 15, 1994
- Decision date
- November 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MND – Ligator, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4400
- Specialty
- Gastroenterology, Urology
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| K022434 | Bard Ultraview Multiple Band Ligator, Model 00700UMND · Traditional | C.R. Bard, Inc. | 08/05/2002SE |
| K013066 | HX-5/6-1 Endoscopic Clipping DeviceMND · Traditional | Olympus America, Inc. | 12/11/2001SE |
| K001744 | Olympus Endoscopic Ligation DeviceMND · Traditional | Olympus America, Inc. | 02/27/2001SE |
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Questions and answers
When was Stiegmann-Goff Endoscopic Ligator cleared by the FDA?
Stiegmann-Goff Endoscopic Ligator (K940661) received a 510(k) decision of Substantially Equivalent on November 28, 1994, 286 days after the submission was received.
What is the product code of K940661?
The FDA product code is MND – Ligator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.