Morse Anesthesia

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K905208 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Homer Mammalok Localization Shield

  Class II

  FDA 510(k) K885090 Active Cleared 14 Feb 1989

• Namic Adb Angiographic Dump Bag

  Class II

  FDA 510(k) K843726 Active Cleared 18 Oct 1984

• Morse(R) Angiographic Catheters

  Class II

  FDA 510(k) K922552 Active Cleared 3 Mar 1993

• Morse Balloon Inflation Device

  Class II

  FDA 510(k) K904275 Active Cleared 3 Jan 1991

• Epic Introducer Sheath

  Class II

  FDA 510(k) K960310 Active Cleared 7 Feb 1996

• Namic Hawkins Universal Drainage Set

  Class II

  FDA 510(k) K873954 Active Cleared 29 Jan 1988

See all devices from North American Instrument Corp. →

• What clinical setting is the Morse Anesthesia device designed for, and how does it support anesthesia administration?

  The Morse Anesthesia device is specifically designed for use in general hospital settings where anesthesia management is required. It facilitates controlled delivery of anesthetic agents during surgical or diagnostic procedures, ensuring precise dosing and monitoring capabilities. This makes it suitable for operating rooms, procedural suites, or any clinical environment where patients require anesthesia.

• Is the Morse Anesthesia device single-use or reusable, and how does this affect its maintenance?

  The Morse Anesthesia device is supplied as a reusable medical instrument. Since it is intended for repeated use, proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety, functionality, and compliance with hospital infection control standards. Reusability also means it should be inspected regularly for wear and tear.

• How was the regulatory approval for this device obtained, and what does the FDA’s 510(k) clearance mean for its use?

  The Morse Anesthesia device received FDA clearance through a Traditional 510(k) submission (K905208), filed in 1990 and granted in 1992. The clearance was based on a determination of substantial equivalence to a legally marketed predicate device, meaning it was deemed to have the same intended purpose and technological characteristics. This approval allows its use in clinical settings where anesthesia administration aligns with its specified indications.

• Who should I contact if I need technical support or additional information about the Morse Anesthesia device?

  For technical support or further details, you can reach out to Robert Franklin at North American Instrument Corp. in Glens Falls, NY. While the provided contact details are from the original submission records, verifying the current contact information directly with the manufacturer is recommended, as administrative details may have changed since 1992.