AUXILIARY INSTRUMENTS FOR URS— 510(k) K971315
Substantially EquivalentRichard Wolf Medical Instruments Corp.
FDA 510(k) clearance K971315 for AUXILIARY INSTRUMENTS FOR URS, Substantially Equivalent on 1997-09-15. Applicant: Richard Wolf Medical Instruments Corp.. Device class: 1.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corp.
- Product code
- Code FCL
- Device class
- Class 1
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
Recent devices under product code FCL
view allMore clearances from Richard Wolf Medical Instruments Corp.
view all- K151282 — core nova Complete Operating Room Endoscopy
- K130423 — THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
- K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
- K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
- K090776 — MEGAPULSE LASER SYSTEM AND FIBERS
Adverse events under product code FCL
product code FCL- Death
- 5
- Total
- 5
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 K971315
K-number listed on FDA's recall record- Z-1422-2023 — FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
- Z-1423-2023 — FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971315.
Data sourced from openFDA. This site is unofficial and independent of the FDA.