Atlas FDA

ENTAXIS NASAL PACKING

FDA 510(k) clearance K984069 · decided 1999-01-25

Clearance details

K-number
K984069
Device name
ENTAXIS NASAL PACKING
Applicant
Les Laboratorires Brothier, S.A.
Decision
Substantially Equivalent
Date received
1998-11-16
Decision date
1999-01-25
Days to decision
70 days
Clearance type
Traditional
Product code
EMX
Device class
1
Regulation number
874.4100
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
St Louis, MO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
PosiSep X BAM Hemostat Dressing/Intranasal Splint (K220326)Hemostasis, LLC2022-11-14
NASALCEASE (K041446)Les Laboratorires Brothier, S.A.2004-07-01
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 (K000108)Bhk Holding2000-05-23
HYLASINE (K993362)Biomatrix, Inc.2000-03-13
HYDROFERA BACTERISTATIC NASAL DRESSING (K983276)Hydrofera, LLC1999-09-14
MEROGEL NASAL DRESSING AND SINUS STENT (K982731)Xomed, Inc.1999-02-02
NOSEBLEED NOSECLIP (K981966)Michael M. Knott, M.D.1998-08-14
DISPOSABLE SILICONE EPISTAXIS CATHETER (K973656)Specialty Surgical Products, Inc.1997-11-18
ULTRACELL PACKING WITH SLEEVE (K973085)Ultracell Medical Technologies, Inc.1997-11-18
VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K (K972922)Interview Medical Technology Corp.1997-10-08
RHINOCELL NASAL PACKINGS (K972459)Boston Medical Products, Inc.1997-08-04
POST-STOP EPISTAXIS CATHETER (K972078)Boston Medical Products, Inc.1997-07-10

Recalls involving this device

No recalls on record reference this clearance.