Surgical Blade Types: Shapes, Steel and FDA Class

Short answer: “Surgical blade types” usually means scalpel blades, which differ in three independent ways: shape (broad curved, pointed, small curved, hooked), steel (carbon or stainless) and supply form (sterile single-use or non-sterile). In the United States, scalpel blades are Class I devices under 21 CFR 878.4800, FDA product code GES. This page is general product information, not medical advice and not a procedure guide.

Definition and scope

Three different products get called a “scalpel”. 21 CFR 878.4800 lists “scalpel blade, scalpel handle, one-piece scalpel” together as manual surgical instruments for general use, described as “a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures” (checked 2026-11-01). A blade is the replaceable cutting part; a handle holds it; a one-piece scalpel combines both. For the basics of the whole instrument see what a scalpel is; for handle fit and the number-by-number list see the scalpel blade sizes chart, which this page deliberately does not repeat.

Specialty cutting instruments, such as ophthalmic knives, are classified in separate regulations within parts 868 to 892 of 21 CFR rather than 878.4800. Examples on CASRAI include the keratome and the crescent blade.

Blade types by shape family

Blade numbers name shapes. Swann-Morton’s No. 3 Range page (manufacturer, checked 2026-11-01) lists blade shapes 6 to 16 plus a double-edged blade 40, with the numbers 06, 09, 10, 10A, 10R, 11, 11P, 12, 12D, 13, 14, 15, 15A, 15C, 15T, 16, 40, E/11, Sabre D/15 and Sabre E/11. WPI, a laboratory supplier, describes four common shapes in its disposable scalpel blade guide (checked 2026-11-01):

Blade	Shape family	Shape described by WPI
No. 10	Broad curved edge	Broad, curved edge
No. 11	Pointed tip	Sharp, pointed tip
No. 12	Crescent-shaped hook	Crescent-shaped hook (see crescent blade)
No. 15	Small curved edge	Small, curved edge

The other numbers in the Swann-Morton list are “also in the range”; this page makes no shape claims for them. Blade 40 is described by Swann-Morton as used in histology. To see how two of the most common numbers compare, read 10 blade vs 15 blade.

Materials and sterility

Swann-Morton states that “all the popular sizes are available in both a Carbon or Stainless steel sterile pack of 100 blades.” So steel type is a separate choice from shape: the same number can come in either steel. Records in the FDA’s AccessGUDID database under product code GES (queried through the openFDA UDI API, 2026-11-01) describe blades as carbon steel and stainless steel, sterile and non-sterile, with single-use flags, and include numbers such as #10, #11, #12, #15C, #20, #21, #22, #24, #25, #34, #36 and a silicone-coated #70GV.

WPI describes disposable scalpels as pre-sterilized, single-use instruments, and states that reuse of disposable blades degrades cutting performance and compromises sterility. Safety-engineered designs are covered on the retractable scalpel page.

FDA class and product code

• Regulation: 21 CFR 878.4800, manual surgical instrument for general use.
• Class: Class I (general controls), exempt from premarket notification (subpart E of part 807), subject to the limitations in 878.9.
• Product code: GES, “Blade, Scalpel”, device class 1, regulation number 878.4800 (openFDA classification API, dataset updated 2026-10-19, checked 2026-11-01).
• Breadth: regulation 878.4800 covers 115 product-code records in openFDA, so it spans many instruments, not only blades.

What a blade listing should state

Built from the fields that manufacturer and GUDID records actually carry, a complete blade listing or record shows:

1. Blade number and shape (for example 10, 11, 12, 15).
2. Steel: carbon or stainless.
3. Sterile or non-sterile supply form.
4. Single-use flag.
5. Handle family it fits; Swann-Morton, for instance, lists its No. 3 Range blades as fitting No. 3, 3L, 5B, 7, 9 and B3 handles.

A listing missing one of these five fields leaves part of the classification above unanswered.

Common misunderstandings

• Number equals size only. A blade number identifies a shape and, within a manufacturer’s range, a handle fit; it is not a single measurement.
• Blade, handle and scalpel are one thing. The CFR names them as separate devices.
• Every “surgical blade” is a scalpel blade. Specialty blades fall under other regulations, and GUDID records filed under GES are not all identical in kind, so the product code alone does not say which cutting shape a record describes.
• Steel type decides sterility. Sterility is a packaging and supply attribute, listed separately from carbon or stainless.

FAQ

What are the types of surgical blades?

For scalpel blades, the practical types are by shape (broad curved #10, pointed #11, hooked #12, small curved #15 and others), by steel (carbon or stainless) and by supply (sterile single-use or non-sterile).

What is the difference between carbon and stainless steel blades?

Both are listed for the same popular numbers; Swann-Morton offers them in a sterile pack of 100 in either steel, and GUDID records describe both materials. The sources cited here do not rank one above the other.

Are surgical blades sterile?

Many are supplied sterile and single-use, and WPI describes disposable scalpels as pre-sterilized, single-use instruments. GUDID also contains non-sterile entries, so the listing’s sterility field matters.

What do the blade numbers mean?

They name a shape within a manufacturer’s range. See the scalpel blade sizes chart for the numbers and handle fit.

Sources

• 21 CFR 878.4800, eCFR, checked 2026-11-01.
• FDA openFDA device classification API, product code GES, checked 2026-11-01.
• FDA AccessGUDID via the openFDA UDI API, product code GES, checked 2026-11-01.
• Swann-Morton, No. 3 Range, checked 2026-11-01.
• WPI, Disposable Scalpel Blade Guide (supplier description), checked 2026-11-01.