Atlas FDA

FLEXTITIP STYLETTE

FDA 510(k) clearance K950380 · decided 1995-02-10

Clearance details

K-number
K950380
Device name
FLEXTITIP STYLETTE
Applicant
Polamedco, Inc.
Decision
Substantially Equivalent
Date received
1995-01-31
Decision date
1995-02-10
Days to decision
10 days
Clearance type
Traditional
Product code
BSR
Device class
1
Regulation number
868.5790
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Inglewood, CA, 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
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip (K162729)Cook Incorporated2017-08-11
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (K962361)Laerdal Medical Corp.1996-09-05
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) (K954771)Laerdal Medical Corp.1996-05-09
MOLLOY INTUBATING STYLETTE (K943104)Molloy Corp.1996-04-18
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE (K955238)Rusch Intl.1996-02-06
LIGHTED FLEXGUIDE (MODIFICATION) (K953677)Scientific Sales Intl., Inc.1995-08-25
RUSCH ENDOTRACHEAL TUBE STYLET (K952100)Rusch, Inc.1995-08-08
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (K952266)Stebar Instrument Corp.1995-06-12
AIRGUIDE STYLETTE (K950713)Polamedco, Inc.1995-05-17
STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (K944729)Coast Medical, Inc.1994-12-21
FLEXGUIDE (K940799)Scientific Sales Intl., Inc.1994-08-18
ENDOSTAR(TM) STYLET (K933598)Fiberoptic Medical Products, Inc.1994-01-25

Recalls involving this device

No recalls on record reference this clearance.