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Castroviejo Needle Holder: Types, Jaws, Sizes and FDA Class

What a Castroviejo needle holder is, how lock and jaw surface differ, sourced lengths, single-use vs reusable, and its FDA Class I status.

Written and maintained by CASRAI Editorial Board

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This page describes products and general use; it is not medical advice.

A Castroviejo needle holder is a fine, spring-handled instrument that grasps and holds a surgical needle, used mainly in eye and oculoplastic surgery. Who it is for: clinic staff, buyers and students who need to tell Castroviejo holders apart from other needle holders and understand the features (lock, jaw surface, single-use or reusable) and the regulatory class that apply.

What is a Castroviejo needle holder?

Needle holders are designed to grasp, hold and maneuver surgical needles (University of Iowa EyeRounds, Needle Holders, page last updated 2017-03-14). The Castroviejo is one pattern within that group. EyeRounds lists the Castroviejo Delicate Straight needle holder with lock, 5.625 inches, on its oculoplastic tray, and documents that it is used to pass most needles in oculoplastic procedures, to tag extraocular muscles during enucleation, and to close a blepharoplasty incision (Castroviejo Delicate Straight Needle Holder w/ Lock).

Who uses it: surgeons and surgical teams performing oculoplastic and related procedures, and the staff who stock and process those trays.

How needle holders are built

Most needle holders feature a clamp mechanism that locks the needle in place. Their jaws can be textured and are short compared with the handles (EyeRounds, Needle Holders). Two features follow from this and are the ones that separate one holder from another:

  • Lock: the locking system on the Castroviejo holder with lock ensures a firm grasp of the needle (EyeRounds).
  • Jaw surface: smooth jaws cause less damage to the needle, while serrated jaws allow a firmer grasp of the needle (EyeRounds).

Types and variants

Variant What the source says Source
Castroviejo with lock Delicate straight pattern, 5.625 in; the lock holds the needle firmly; available in various sizes EyeRounds, Castroviejo Delicate Straight Needle Holder w/ Lock
Castroviejo without lock Exists as a listed device (a Blink Medical model, 90-7002); it is recorded as single-use FDA AccessGUDID record 05060480408166
Smooth-jaw holder Less damage to the needle EyeRounds, Needle Holders
Serrated-jaw holder Firmer grasp of the needle EyeRounds, Needle Holders
Single-use vs reusable The GMDN nomenclature has separate terms: "Suturing needle holder, single-use" (code 47568) and a reusable counterpart AccessGUDID, device 05060480408166

Sizes that matter

Instrument Length Source
Castroviejo Delicate Straight with lock 5.625 in EyeRounds
Webster needle holder 5 in EyeRounds, Needle Holders

EyeRounds notes that the Castroviejo is available in various sizes, so a single length should not be assumed for the pattern. The AccessGUDID record for the single-use model shows no device sizes.

Regulatory status in the United States

FDA’s regulation for manual ophthalmic surgical instruments, 21 CFR 886.4350, describes a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures, and classifies it as Class I (general controls), exempt from 510(k) subject to the limitations in 886.9. The list of examples in that section names ophthalmic forceps, scissors and suturing needles; it does not name needle holders. For general surgery, 21 CFR 878.4800 covers nonpowered, hand-held or hand-manipulated devices, reusable or disposable, also Class I and 510(k)-exempt subject to 878.9. Which regulation applies to a specific product depends on its labelled intended use, so check the manufacturer’s labelling rather than assuming a section.

How to choose

The published sources support these distinctions: whether the instrument has a lock, whether its jaws are smooth or serrated (needle protection against grip), its length, and whether it is single-use or reusable. Beyond those, follow the manufacturer’s instructions for use for the needle sizes and procedures a specific instrument is labelled for.

Safe use and handling basics

  • Use a needle holder only for what it is designed to do: grasp, hold and maneuver surgical needles.
  • A device recorded as single-use is not intended to be reused; for reusable instruments, cleaning and sterilization follow the manufacturer’s instructions for use.
  • Choice of instrument and technique for a patient is a clinical decision for the surgeon.

Common points of confusion

  • "Castroviejo" is not one size. EyeRounds describes it as available in various sizes.
  • Not every needle holder is reusable. A single-use Castroviejo without lock is listed in FDA’s AccessGUDID.
  • Class I does not mean unregulated. Class I devices are subject to general controls.

Related instrument guides

Needle holders sit alongside other hand instruments. See what a hemostat is, orthopedic surgical instruments and laparoscopic instruments. Procurement staff browsing the product range can find forceps in the lac.us catalogue.

FAQ

What is a needle holder?

A hand instrument designed to grasp, hold and maneuver surgical needles. Most have a clamp mechanism that locks the needle in place (EyeRounds). AccessGUDID defines the GMDN term as a hand-held manual surgical instrument designed to grasp a suture needle.

What are needle holder types and sizes?

Types differ by lock or no lock, smooth or serrated jaws, and single-use or reusable. Sourced lengths on this page are 5.625 in (Castroviejo Delicate Straight with lock) and 5 in (Webster).

What are needle holders used for?

The Castroviejo is documented as used to pass most needles in oculoplastic procedures, tag extraocular muscles during enucleation and close a blepharoplasty incision (EyeRounds).

How does a Mayo-Hegar differ?

Mayo-Hegar is a separate needle-holder pattern. This page covers the Castroviejo and the general jaw and lock features above; consult the Mayo-Hegar manufacturer’s specifications for its dimensions.

Sources

All sources below were checked on 2026-10-30.

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