Company ยท DE
Richard Wolf GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 1996. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2025 | Richard Wolf GmbH PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager). Open, Classified |
ISA | None listed |
| Apr 24, 2023 | Richard Wolf GmbH FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 Open, Classified |
FCL | None listed |
| Apr 24, 2023 | Richard Wolf GmbH FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 Open, Classified |
FCL | None listed |
| Apr 24, 2023 | Richard Wolf GmbH FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 Open, Classified |
FCL | K971315 |
| Apr 24, 2023 | Richard Wolf GmbH FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 Open, Classified |
FCL | K971315 |
| Jun 25, 2021 | Richard Wolf GmbH CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 Terminated |
FJL | K062720 |
| Jul 27, 2020 | Richard Wolf GmbH Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and access Terminated |
HIF | K000180 |
| Oct 17, 2018 | Richard Wolf GmbH Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of path Open, Classified |
KTI | None listed |
| Mar 11, 2018 | Richard Wolf GmbH RICHARD WOLF TUBE SET FOR TEM, REF 4170.801.
Used for the transanal endoscopic microsurgery. Terminated |
HIF | K000180 |
| Jul 24, 2017 | Richard Wolf GmbH Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.
Product Usage:
Device is a standard p Open, Classified |
HRX | K953868 |