FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM— 510(k) K971305
Substantially EquivalentGynecare Innovation Center
FDA 510(k) clearance K971305 for FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM, Substantially Equivalent on 1997-08-11. Applicant: Gynecare Innovation Center. Device class: 2.
Clearance details
- Applicant
- Gynecare Innovation Center
- Product code
- Code HIH
- Device class
- Class 2
- Regulation
- 21 CFR 884.1690
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code HIH
view all- K254294 — Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
- K260984 — HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)
- K253020 — Strauss Surgical Resection Instruments
- K254050 — Manual Tissue Removal Device
- K254251 — InnovexView (GC146-17, GC150-20, GC155-23)
More clearances from Gynecare Innovation Center
view all- K980393 — SOPRANO CRYO-THERAPY SYSTEM
- K964441 — FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
- K964892 — FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
- K963872 — FEMRX MORCELLATOR SYSTEM
- K962506 — [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
Adverse events under product code HIH
product code HIH- Death
- 18
- Injury
- 973
- Malfunction
- 5,071
- Other
- 1
- Total
- 6,063
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.