ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)— 510(k) K131637
Substantially EquivalentRotation Medical, Inc.
FDA 510(k) clearance K131637 for ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE), Substantially Equivalent on 2013-07-12. Applicant: Rotation Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Rotation Medical, Inc.
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code GDW
view allMore clearances from Rotation Medical, Inc.
view allAdverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K131637
K-number listed on FDA's recall record- Z-3096-2024 — ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
- Z-3097-2024 — ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131637.
Data sourced from openFDA. This site is unofficial and independent of the FDA.