Product code FWN— Ear, Nose, Throat
'EXMOOR' DAS GUPTA LARYNGEAL KEEL
- Classification name
- Prosthesis, Larynx (Stents And Keels)
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code FWN
FDA has cleared devices under product code FWN between 1984 and 2009, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2009
- 2000
- 1996
- 1990
- 1989
- 1987
- 1986
- 1984
Top applicants under product code FWN
Recent clearances under product code FWN
- K091135 — RUTTER SUPRA STOMAL STENTS
- K000154 — ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
- K962693 — MONTGOMERY RADIOPAQUE LARYNGEAL KEEL
- K896667 — LORENZ STENT
- K884810 — SILICONE LARYNGEAL STENT
- K864936 — 'EXMOOR' DAS GUPTA LARYNGEAL KEEL
- K853726 — LARYNGEAL
- K842800 — MONTG. LARYNGEAL KEEL
- K842287 — MONTGOMERY LARYNGEAL STENT
- K841347 — LARYNGEAL STENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.