Home / 510(k) Clearances / K802416

510(k) K802416

SALEM/RESCE INTUBATION GUIDE by Scientific Sales Intl., Inc. — Product Code BSR

K802416 is an FDA 510(k) premarket notification submitted by Scientific Sales Intl., Inc. for the device "SALEM/RESCE INTUBATION GUIDE". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Scientific Sales Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
October 6, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Tracheal Tube
Device Class
Class I
Regulation Number
868.5790
Review Panel
AN
Submission Type

Other clearances by Scientific Sales Intl., Inc.

  • K953677 — LIGHTED FLEXGUIDE (MODIFICATION) (August 25, 1995)
  • K940799 — FLEXGUIDE (August 18, 1994)
  • K860996 — SANASSAY IC TEST (March 30, 1987)
  • K862087 — SANTEST 1AP (December 3, 1986)
  • K861336 — IAP PLATE TEST (April 25, 1986)
  • K853284 — MYREADER 7 (October 4, 1985)
  • K853285 — MYWASHER 5 (October 4, 1985)
  • K853380 — SPR 2 AUTODILUTER (September 12, 1985)
  • K853379 — PLATE INCUBATOR (September 3, 1985)
  • K833022 — AIR UTERINE DISPLACER-AUD 120 (October 14, 1983)

Other clearances for product code BSR

  • K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exc (August 11, 2017)
  • K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (September 5, 1996)
  • K954771 — TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRA (May 9, 1996)
  • K943104 — MOLLOY INTUBATING STYLETTE (April 18, 1996)
  • K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE (February 6, 1996)
  • K953677 — LIGHTED FLEXGUIDE (MODIFICATION) (August 25, 1995)
  • K952100 — RUSCH ENDOTRACHEAL TUBE STYLET (August 8, 1995)
  • K952266 — SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (June 12, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K950380 — FLEXTITIP STYLETTE (February 10, 1995)

FDA data resources