Arrow Surgical Drapes

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

Full name

Arrow International, Inc., Surgical Drapes

510(k) Number

K071491 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Brachial Plexus Catheter - Bp-01200

  Class II

  FDA 510(k) K874105 Active Cleared 24 Nov 1987

• A2 Port, Dual Lumen System With Detached Catheter, Catalog # AP-01518

  Class II

  FDA 510(k) K963684 Active Cleared 24 Oct 1996

• Arrow Picc-Peripherally Inserted Central Catheter

  Class II

  FDA 510(k) K930129 Active Cleared 28 Mar 1994

• Hemosonic 200HEMODYNAMIC Monitor

  Class II

  FDA 510(k) K040802 Active Cleared 28 Apr 2004

• Needleless Injection Cannula

  Class II

  FDA 510(k) K923653 Active Cleared 13 May 1993

• Arrow Echogenic Introducer Needle Component

  Class II

  FDA 510(k) K071998 Active Cleared 26 Sep 2007

See all devices from Arrow Intl., Inc. →

• Are these drapes reusable or meant for single-use only, and why does that matter in an operating room setting?

  These drapes are explicitly designed for single-use only, as stated in the description. This is critical in surgical settings because reusing drapes could compromise sterility, increasing the risk of microbial contamination at incision sites. Single-use ensures each patient receives a fresh, sterile barrier, aligning with best practices for infection control and patient safety.

• What materials are used in these drapes, and how do they contribute to their function during surgery?

  The drapes are constructed from barrier, absorbent, and repellent materials, which work together to prevent microbial contamination while maintaining a dry surgical field. The barrier material isolates the incision site, the absorbent layer helps manage fluids, and the repellent properties ensure liquids (like blood or irrigation fluids) don’t penetrate through, keeping the sterile field intact.

• Do these drapes come with adhesive features, and if so, what’s their purpose in securing them to the patient?

  Yes, these drapes incorporate medical-grade adhesive along their edges. The adhesive ensures a secure, leak-proof seal around the patient’s skin, preventing the drape from shifting during surgery and reducing the risk of contamination from external sources. This is particularly useful in procedures where maintaining a sterile field is critical.

• Are there different sizes or models available, and if so, how would a clinician determine the right fit for a patient?

  While the provided data does not specify exact sizes or models, the description mentions fenestrations (cutouts) for site access, implying customizable or pre-sized options may exist to accommodate various incision locations. Clinicians would typically select the drape based on the procedure type, incision size, and patient anatomy, ensuring full coverage of the sterile field while allowing necessary access to the surgical site.

• How should these drapes be stored to maintain their sterility before use, and what precautions should be taken?

  Since these drapes are sterile and disposable, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is likely sealed to preserve sterility, so any breach (e.g., punctures, contamination) would invalidate the drape for use. Always check the packaging integrity before opening to ensure sterility is maintained until use.